1. Field of the Invention
The present invention relates to an ostomy appliance and to a method of applying an ostomy appliance body side member around a stoma.
In connection with surgery for a number of diseases in the gastrointestinal or urinary tract a consequence is, in many cases, that the colon, the ileum or the ureter has been exposed surgically and the patient is left with an abdominal stoma, or, in nephrostomy or ureterostomy, the ureter or a catheter is exposed in the back or the chest region or abdominal region, and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma/ureter/catheter. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
Ostomy appliances are well known. Such appliances may be two-piece or one-piece appliances. In both types of appliances, an adhesive barrier member (or base plate) is attached to the wearer's abdomen/back/chest. In case of a one-piece appliance, a receiving member or bag is permanently attached to the base plate. In case of a two-piece appliance, the adhesive barrier member forms part of a body side member and a receiving member or bag is attached releasably to the body side ostomy member for receiving exudates from the stoma.
When using one-piece appliances, the whole appliance, including the adhesive skin barrier securing the appliance to the skin is normally removed and replaced by a fresh appliance. When using two-piece appliances, the body side ostomy member is left in place up to several days, and only the receiving member or bag attached to the body side member is replaced. The attachment means for attaching an ostomy receiving bag may e.g. be a system known per se comprising matching coupling rings or matching flanges and adhesive surfaces engaging with and sealing against a flange area of the body side member.
It is necessary to change the body side member of a two-piece appliance when the centre part of the adhesive wafer has been sufficiently deteriorated to allow access of the aggressive exudates to the skin surrounding the stoma, irrespective of the fact that the wafer as such has a much longer wearing time. The access of aggressive exudates to the skin is causing skin problems.
Frequent changing of the body side member of a two-piece appliance is undesirable due to the irritation of the skin and the quality of life of the user may be improved and the nuisance of the wearing of an ostomy appliance reduced if the intervals between exchanging of body side member can be increased.
The service time of the body side ostomy member depends inter alia of the amount and the aggressiveness of the exudates and of the sealing between the stoma and the body side ostomy member.
The sealing depends on the fit to the stoma. Conventionally, only a limited number of standard appliances having holes of different size are available and the user or an assistant must customise the body side member by cutting the edge of the hole to adapt the body side member to the stoma.
2. Description of the Related Art
When cutting the edge of the hole of an adhesive wafer of a conventional one-piece ostomy appliance for adapting the same to the size and shape of a stoma the cutting is complicated by the fact that in order to secure discretion, for decorative purposes and for providing softness, low noise generation and comfort the bag is often made from an opaque material or covered and/or provided with a cover or front layer rendering it very difficult, if not impossible for the user or the nurse to observe the stoma area during determination of a cutting line for adaptation of the hole or when applying the appliance.
Published International Patent Applications Nos. WO 98/17212 and WO 98/53771 disclose ostomy appliances comprising a body side member comprising an adhesive wafer for securing the appliance to the user's skin, said wafer having a hole for receiving a stoma, and an optionally separately exchangeable receiving member or bag secured to the body side ostomy member for receiving secretions from the ostomy said ostomy appliance further comprising a sealing member disposed in the hole of the wafer surrounding the stoma and having a hole for accommodating the stoma.
The ostomy appliance disclosed in Published International Patent Application No. WO 98/53771 has a sealing member having balanced plastic and elastic properties allowing a better adaptation of the hole of the ostomy appliance to a stoma by a temporary enlarging of the hole by everting or rolling up the inner rim of the hole for accommodating the stoma.
WO 98/17212 and WO 98/53771 only teach the use of such a sealing member together with two-piece ostomy appliances and do neither disclose nor indicate how to use a sealing member together with one-piece ostomy devices.
It has been found desirable in practice to make use of separate sealing members for facilitating the adaptation of an ostomy appliance and the sealing between the ostomy appliance and the stoma.
If used with a one-piece ostomy appliance, such a sealing member would be difficult to manipulate for several reasons.
Firstly, it is very difficult to adapt the sealing member to the stoma after applying the ostomy appliance if the sealing member has a tacky surface on the side facing the bag as it will then adhere to the bag during attempts to adapt the sealing member to the stoma which must be performed by pressing the wall of the bag against the sealing member. Then, also a risk exists that the wall of the bag is torn when trying to disengage the contact.
Secondly, due to the measures to secure discretion, for decorative purposes and for providing softness, low noise generation and comfort stated above it also in this case very difficult, if not impossible for the user or the nurse to observe the stoma area during adaptation of such a sealing member when applying one-piece appliances.